Validation Compliance Annual

This indispensable guide offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries - addressing all significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories.
Elucidating up-to-the-minute industry changes and international concerns, Validation Compliance Annual 1995 examines Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Automated laboratory Practices (GALPs)... provides unabridged texts of U.S. and European Union regulatory requirements as well as summaries of the validation requirements of other nations... furnishes complete guidelines and tools for system validation... supplies an in-depth look at problems related to inadequate system validation, including actual regulatory citations for noncompliance... explains the rationale behind regulatory compliance policies and inspectional practices... assesses the future of regulatory and industry trends... and more.
Containing key bibliographic citations and a thorough glossary of validation terms, Validation Compliance Annual 1995 is an incomparable day-to-day workbook for analytical, pharmaceutical, food, and environmental chemists; instrumentation specialists; industrial, bio-process, chemical, and pharmaceutical engineers; quality and reliability managers and directors; laboratory managers and technicians; computer scientists; and upper-level undergraduate and graduate students in these disciplines.